Heurnova:
Comprehensive Solutions for Regulated, High-Impact, and Fast-Growing Organizations
Heurnova brings together the precision of engineering, the rigor of compliance, the clarity of strategy, and the creative power of modern marketing. We help organizations build strong foundations, reduce risk, and scale sustainably by combining technical depth with human-centered design. Our approach integrates regulatory expertise, systems engineering, brand development, and business strategy into one cohesive framework — ensuring every decision is informed, traceable, and aligned with long-term goals.
Whether you’re navigating complex medical device requirements, strengthening operational structure, refining your brand, or preparing for growth, we create solutions that are practical, defensible, and built for real-world performance. At Heurnova, we don’t just solve problems — we build systems that elevate your organization from the inside out.
Medical Device Compliance Services
Our compliance services ensure your organization meets the rigorous requirements of global medical device, chemical, and operational standards. We translate complex regulations into clear, actionable pathways—closing gaps, building documentation systems, and preparing you for audits with confidence. Whether you need ISO 13485, EU MDR, REACH, or RoHS support, we create structures that protect users, reduce risk, and strengthen your regulatory readiness across the full product lifecycle.
Engineering Services
We bring engineering precision to every stage of product and process development. From design verification and validation to risk management, root cause analysis, and QMS architecture, our approach blends technical expertise with real-world practicality. We ensure your devices are safe, effective, and built on defensible evidence—supporting smooth development, compliant transfer, and long-term performance. When clarity and traceability matter, engineering leads the way.
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